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Vitamin D3 Supplementation and the T Cell Compartment in Multiple Sclerosis (MS)

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ClinicalTrials.gov Identifier: NCT00940719
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : August 11, 2010
Sponsor:
Collaborator:
Orbis Medical Centre
Information provided by:
Maastricht University Medical Center

Study Description
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Brief Summary:
In patients with Relapsing Remitting Multiple Sclerosis (RRMS), the investigators observed a positive correlation between regulatory T cell (Treg) function and vitamin D status. The present goal is to assess whether Treg function improves on supplementation with vitamin D3.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Dietary Supplement: vitamin D3 Not Applicable

Detailed Description:

In several studies, Multiple Sclerosis (MS) incidence and disease activity has been related with vitamin D status. We observed that RRMS patients who remained relapse free before blood collection had a better vitamin D status than patients who experienced relapses (Smolders et al. Mult Scler 2008;17:1220-1224). Since vitamin D3 is a potent promotor of T cell regulation in vitro (Smolders et al. J Neuroimmunol 2008;194:7-17), we hypothesised that a promotion of Treg function in MS patients might underlie its association with MS disease activity. In a cohort of RRMS patients, we observed a positive correlation of Treg function with vitamin D status (Smolders et al. PLoS ONE 2009;4:e6635). Furthermore, vitamin D status correlated positively with a Th1/Th2-balance which was more directed towards Th2. In the present study, we will assess whether treatment of RRMS patients with vitamin D3 promotes T cell regulation.

In the present study, RRMS patients will be supplemented with vitamin D3, and regulatory T cell tests will be performed before and after supplementation.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Vitamin D3 Supplementation on the T Cell Compartment in Multiple Sclerosis; a Pilot Study
Study Start Date : August 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vitamin D3
Patients receive 1dd 500ug vitamin D3 for 3 months
 Dietary Supplement: vitamin D3
Oil-based solution, 1 dose of 500 microgram each day, during 3 months.
Other Name: Vigantol Oil (Merck)


Outcome Measures
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Primary Outcome Measures :
  1. T cell regulation [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. serum 25-hydroxyvitamin D levels [ Time Frame: 3 months ]
  2. calcium metabolism [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsing Remitting MS (Revised MCDonald criteria 2005)
  • Age > 18 years

Exclusion Criteria:

  • Progressive MS phenotype
  • Abnormalities of vitamin D hormonal system other than low dietary intake or limited sun exposure
  • Intake of drugs that influence vitamin D homeostasis other than corticosteroids
  • Conditions with in increased susceptibility to hypercalcemia
  • Alcohol or drug abuse
  • Pregnancy or the intention to become pregnant within the study period
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940719


Locations
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Netherlands
Orbis Medical Center
Sittard, Netherlands, 6130MD
Sponsors and Collaborators
Maastricht University Medical Center
Orbis Medical Centre
Investigators
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Study Director: Raymond Hupperts, M.D., Ph.D. Orbis Medical Center Sittard, Maastricht Univeristy Medical Center Maastricht
Principal Investigator: Joost Smolders, M.D. Maastricht University Medical Center
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. dr. Raymond Hupperts, M.D., Ph.D., Orbis Medical Center Sittard, Maastricht University Medical Center Maastricht
ClinicalTrials.gov Identifier: NCT00940719    
Other Study ID Numbers: MUMC09T43
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: August 2010
Keywords provided by Maastricht University Medical Center:
Multiple Sclerosis
Regulatory T cell function
Vitamin D
Vitamin D3
25-hydroxyvitamin D
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Vitamin D
Cholecalciferol
Vitamins
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents